NCT04640441

Effect of Sit-to-Stand Intervention in the Intensive Care Unit Survivors

Effect of Sit-to-Stand Intervention in the Intensive Care Unit Survivors: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

"Sit-to-stand" is key to independent living. For intensive care unit (ICU) survivors, failure to perform sit-to-stand results in bed-bound status, unable participating in important activities of daily living (ADLs) or instrumental ADLs. Recent studies indicated that 31% of ICU survivors remained bed-bound and unable to "sit-to-stand" after returning home. Our preliminary findings further indicated that 70% of ICU survivors who had the ICU-acquired weakness (ICU-AW) were unable to "sit-to-stand" one-month after ICU discharge. The aim of this 3-year research project was to develop a feasible and effective "sit-to-stand" intervention (STS intervention) and to examine effects of the STS Care in improving ICU survivors' "sit-to-stand" ability, walking independently, physical function, and rates of bed-bound and mortality one year following ICU discharge.

Detailed description

The trial was approved by the Human Research Ethics Committee at the study site before enrollment. Adult ICU patients (≥ 20 years) admitted consecutively to six medical ICUs of a university affiliated medical center was eligible for the study if they were unable to "sit-to-stand" independently at ICU discharge. Upon signing informed consent, participants will be first stratified by "able to stable sitting" or "unable to stable sitting" and then randomized separately into the intervention or usual care groups, according to computer-generated randomization tables. Participants in the intervention group received both usual care and the STS intervention. The hospital-based (up to 14 days) STS Intervention was provided daily by a independent trained nurse. STS care includes anti-gravity and resistant exercise (intensity based on patients' tolerance), repetitive sit-to-stand practice, and advice on sit-to-stand strategies. A comprehensive functional evaluation (rate of sit-to-stand, rate of walking independently, FSS-ICU scores, numbers of sit-to-stand repetitions in 30 seconds, MRC scores, muscle strength at knee extensors, scores of the barthel index for activities of daily living (ADL), scores of instrumental activities of daily living scale (IADL), the walking distance by the 6-minute walk test, rate of bed-bound status, and rate of mortality) was assessed by a blinded research nurse after ICU discharge at 48hours, 14 day, 1, 3, and 12 months. ICU-AW diagnosis (yes or no) at ICU discharge and daily caloric intake were selected a priori as pre-defined covariates and will be included in the analysis.

Conditions

• Unable to Sit-to-stand
• ICU Survivor

Interventions

Type	Name	Description
OTHER	Sit-to-stand Intervention	1. Passive, anti-gravity range of motion(ROM) exercise of lower legs and sitting balance exercise. 2. Sit-to-stand exercise 3. Education on strategies to facilitate sit-to-stand movement and safe transfer

Timeline

• Start date: 2020-09-14
• Primary completion: 2023-12-31
• Completion: 2024-11-08
• First posted: 2020-11-23
• Last updated: 2026-04-15

Locations

1 site across 1 country: Taiwan